Norm

NPR-ISO/TR 24971:2013 en

Medische hulpmiddelen- Richtlijn voor de toepassing van ISO 14971

52,53

Over deze norm

Status Definitief
Aantal pagina's 12
Commissie Medische hulpmiddelen - horizontale onderwerpen
Gepubliceerd op 01-07-2013
Taal Engels
This Technical Report provides guidance in addressing specific areas of ISO 14971 when implementing risk management. The guidance is intended to assist manufacturers and other users of the standard to: - understand the role of international product safety and process standards in risk management; - develop the policy for determining the criteria for risk acceptability; - incorporate production and post-production feedback loop into risk management; - differentiate between ?information for safety? and ?disclosure of residual risk?; and - evaluate overall residual risk.

Details

ICS-code 11.040.01
Nederlandse titel Medische hulpmiddelen- Richtlijn voor de toepassing van ISO 14971
Engelse titel Medical devices - Guidance on the application of ISO 14971

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